The Danish TURNER Cryopreservation Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age2-17
SponsorUniversity of Aarhus
About this trial
The goal of this clinical trial is to investigate if cryopreservation of ovarian tissue in girls with Turner syndrome can improve their fertility and lead to increased number of liveborn babies of Turner syndrome mothers. Women with Turner syndrome suffer from premature ovarian insufficiency which leads to infertility and lack of estrogen.
The main questions it aims to answer are:
* Does the number of pregnancies and liveborn children increase after cryopreservation of ovarian tissue in turner syndrome? * Is the possible to predict when a girl with Turner syndrome reach menopause using monitoring of sex hormones? * Is it possible to identify any genes causing ovarian failure in Turner syndrome females?
Participants between 2-18 years old will be asked to participate in a laparoscopic surgery and removal of one ovary in order to cryopreserve the tissue until adulthood. The the cortical tissue will be autotransplanted in order to preserve fertility. The participant will during the study period be monitored using sex hormones.
Furthermore, the investigators wish to investigate the ovarian tissue using RNA sequencing and DNA methylation analysis.
No comparison group is present.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
45,X karyotype or other Turner variant karyotypes (45,X/46,XX mosaicism, ring X mosaicism, isochromosome X)
Age 2-17 years old
Ability to participate in a physical examination including a cardiac examination.
Signed consent from both parents.
Disqualifiers
Severe cardiac disease which inhibits safe surgery and pregnancy.
Karyotype with Y chromosome material
Mental retardation
Trial design
Design model
Single group
Treatments tested in this trial
laparoscopic cryopreservation of one ovary
Procedure/SurgeryLaparoscopic removal of one ovary as child. In adulthood cortical tissue is replaced in the abdomen in order to improve fertility and pregnancy rates in Turner syndrome women.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Number of pregnancies in Turner syndrome women
The number of pregnancies
Time frame
20 to 30 years after cryopreservation2
Number of miscarriages in pregnant Turner syndrome women
The number of miscarriages
Time frame
20 to 30 years after cryopreservation3
Number of liveborn children birthed by Turner syndrome women
The number of liveborn children
Time frame
20 to 30 years after cryopreservationSecondary outcomes
1
Number of ovarian follicles.
The number of primordial follicles/mm3 in ovarian tissue.
Time frame
2-5 days after surgery2
To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.
blood concentration of FSH meassured from a yearly blood sample.
Time frame
From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 years3
To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.
Blood concentration of LH meassured from a yearly blood sample.
Time frame
From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 years4
To evaluate predictors of premature ovarian failure in Turner syndrome under 18 years after ovarian cryopreservation.
blood concentration of AMH meassured from a yearly blood sample.
Time frame
From the date of inclusion in study until autotransplantation. Timeframe can be up to 30 yearsSponsors and contacts
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Source ClinicalTrials.gov